Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

NCT04652492 | Unknown Phase 2

• 1 other identifier: BGB-A317-2004-IIT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.

Conditions

Hepatocellular Carcinoma

Keywords

TACE; tislelizumab

Outcome Measures

Primary Outcomes (1)

• TTP assessed by independent review committee(IRC)

  Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).

  up to 24 months after enrollment or study close

Secondary Outcomes (7)

• TTP assessed by investigators

  An expected average of 8 months

• PFS

  An expected average of 8 months

• ORR

  An expected average of 8 months

• DCR

  An expected average of 8 months

• DOR

  An expected average of 8 months

Study Arms (1)

Tislelizumab in combination with cTACE

EXPERIMENTAL

Tislelizumab in combination with on-demanded cTACE

Drug: Tislelizumab in combination with cTACE

Interventions

Tislelizumab in combination with cTACE DRUG

On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)

Also known as: BGB-A317

Tislelizumab in combination with cTACE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old on the day the patients voluntary to participate in the study and signing in ICF.
• Histological or clinical diagnosis of HCC.
• BCLC stage C patients ineligible for surgical resection or liver transplantation.
• No prior systemic therapy for HCC (including immunotherapy).
• Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
• Child-Pugh A-B7.
• ECOG PS 0-1.
• Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR \> 30 ml/min/1.73 m2)
• For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
• life expectancy of more than 3 months.
• Patients must be able to understand and willing to sign a written informed consent document.
• Patients suitable for TACE therapy assessed by investigators.

You may not qualify if:

• Tumor thrombus involving main trunk of portal vein or inferior vena cava.
• Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
• Disease history of grade 2 or more hepatic encephalopathy.
• Extrahepatic metastasis on baseline imaging.
• HIV infection or syphilis.
• Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
• Tumor diffuse.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu, MD

CONTACT

86-13851420979; zhuhaidong9509@163.com

Rui-Jie Du, MD

CONTACT

86-25-83262224; ruiwind1227@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: October 27, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)